Apparatus, system, and method for vasculature obstruction removal

ABSTRACT

In embodiments of an obstruction removal device, system, and/or method, a removal tool is disposed at a distal end of a delivery tool and configured to at least partially separate an obstruction from an inner surface of a vasculature. An expandable member is also coupled to the delivery tool. The expandable member includes a proximal end that is free or slidably coupled to the delivery tool. The proximal end of the expandable member is configured to invert or slide toward a distal end of the expandable member, thereby causing the expandable member to surround at least a portion of the obstruction and the removal tool so that the obstruction is captured between the expandable member and the removal tool, when the delivery tool is withdrawn from the vasculature to remove the removal tool and the obstruction from the vasculature.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a continuation of U.S. Nonprovisionalapplication Ser. No. 16/736,279, filed Jan. 7, 2020, and titled“APPARATUS, SYSTEM, AND METHOD FOR VASCULATURE OBSTRUCTION REMOVAL,”which claims the benefit under 35 U.S.C. § 119(e) of U.S. ProvisionalApplication Ser. No. 62/789,584, filed Jan. 8, 2019, and titled“APPARATUS, SYSTEM, AND METHOD FOR VASCULATURE OBSTRUCTION REMOVAL,”which is incorporated herein by reference in its entirety.

TECHNICAL FIELD

The present invention generally relates to medical devices, and, moreparticularly, to medical devices for removing vascular obstructions.

BACKGROUND

Obstruction removal systems/devices may operate by lodging theobstruction in a component of the removal system. In some cases, theobstruction may dislodge. Dislodgement of the obstruction substantiallyincreases the risk for potential complications, such as stroke or heartattack. Thus, it is desirable to secure the obstruction safely forremoval from the body.

SUMMARY

An obstruction removal system is disclosed. In one or more embodiments,the obstruction removal system includes a guide catheter configured tobe inserted within a vasculature and a delivery tool having a distal endconfigured to be inserted within the guide catheter and disposedproximate to an obstruction in the vasculature. The obstruction removalsystem further includes a removal tool disposed at the distal end of thedelivery tool. The removal tool is configured to at least partiallyseparate an obstruction from an inner surface of a vasculature. Anexpandable member is also coupled to the delivery tool. The expandablemember includes a proximal end that is free or slidably coupled to thedelivery tool. The proximal end of the expandable member is configuredto invert or slide toward a distal end of the expandable member, therebycausing the expandable member to surround at least a portion of theobstruction and the removal tool so that the obstruction is capturedbetween the expandable member and the removal tool, when the deliverytool is withdrawn from the vasculature to remove the removal tool andthe obstruction from the vasculature.

More generally, an obstruction removal device is disclosed. In one ormore embodiments, the obstruction removal device includes a removal tooldisposed at a distal end of a delivery tool and configured to at leastpartially separate an obstruction from an inner surface of avasculature. The obstruction removal device also includes an expandablemember coupled to the delivery tool. The expandable member includes aproximal end that is free or slidably coupled to the delivery tool. Theproximal end of the expandable member is configured to invert or slidetoward a distal end of the expandable member, thereby causing theexpandable member to surround at least a portion of the obstruction andthe removal tool so that the obstruction is captured between theexpandable member and the removal tool, when the delivery tool iswithdrawn from the vasculature to remove the removal tool and theobstruction from the vasculature.

A method for removing an obstruction from a vasculature is alsodisclosed. In one or more embodiments, the method includes the steps of:inserting a guide catheter within the vasculature; extending a deliverytool through the guide catheter so that a distal end of the deliverytool is disposed proximate to the obstruction in the vasculature;removing at least a portion of the obstruction in the vasculature with aremoval tool disposed at the distal end of the delivery tool, whereinthe removal tool is configured to at least partially separate theobstruction from an inner surface of the vasculature; and surrounding atleast a portion of the obstruction and the removal tool with anexpandable member coupled to the delivery tool, the expandable memberincluding a proximal end that is free or slidably coupled to thedelivery tool, wherein the proximal end of the expandable member isconfigured to invert or slide toward a distal end of the expandablemember, so that the obstruction is captured between the expandablemember and the removal tool, when the delivery tool is withdrawn fromthe vasculature to remove the removal tool and the obstruction from thevasculature.

This Summary is provided solely as an introduction to subject matterthat is fully described in the Detailed Description and Drawings. TheSummary should not be considered to describe essential features nor beused to determine the scope of the Claims. Moreover, it is to beunderstood that both the foregoing Summary and the following DetailedDescription are example and explanatory only and are not necessarilyrestrictive of the subject matter claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The detailed description is described with reference to the accompanyingfigures. The use of the same reference numbers in different instances inthe description and the figures may indicate similar or identical items.Various embodiments or examples (“examples”) of the present disclosureare disclosed in the following detailed description and the accompanyingdrawings. The drawings are not necessarily to scale. In general,operations of disclosed processes may be performed in an arbitraryorder, unless otherwise provided in the claims.

FIG. 1A illustrates a cross-sectional side view of a guide catheter ofan obstruction removal system deployed within a vasculature, inaccordance with one or more embodiments of the present disclosure.

FIG. 1B illustrates a cross-sectional side view of an obstructionremoval device of the obstruction removal system deployed through theguide catheter, wherein the obstruction removal device includes aremoval tool and an expandable member attached to a delivery tool thatis fed through the guide catheter using an intermediate catheter, inaccordance with one or more embodiments of the present disclosure.

FIG. 1C illustrates a cross-sectional side view of the obstructionremoval device of the obstruction removal system deployed within thevasculature, wherein the intermediate catheter is pulled back (and/orthe delivery tool is pushed forward) to unsheathe the obstructionremoval device so that the obstruction removal device can engage theobstruction with the removal tool to at least partially separate theobstruction from an inner surface of the vasculature, in accordance withone or more embodiments of the present disclosure.

FIG. 1D illustrates a cross-sectional side view of the obstructionremoval device of the obstruction removal system deployed within thevasculature, wherein a proximal end of the expandable member is beingslid toward a distal end of the expandable member, and wherein a middleportion of the expandable member is being folded over the distal end ofthe expandable member and at least a portion of the removal tool, sothat the obstruction is captured between the expandable member and theremoval tool, as the delivery tool is being removed from the vasculatureto remove the removal tool and the obstruction from the vasculature, inaccordance with one or more embodiments of the present disclosure.

FIG. 1D-1 illustrates a cross-sectional side view of the obstructionremoval device of the obstruction removal system deployed within thevasculature, wherein a proximal end of the expandable member is beingslid toward a distal end of the expandable member, and wherein a middleportion of the expandable member is being folded over the distal end ofthe expandable member and at least a portion of the removal tool, sothat the obstruction is captured between the expandable member and theremoval tool, as the delivery tool is being removed from the vasculatureto remove the removal tool and the obstruction from the vasculature,wherein the friction between the expandable member and the inner surfaceof the vasculature causes the expandable member to invert and/or foldover itself, in accordance with one or more embodiments of the presentdisclosure.

FIG. 1D-2 illustrates a cross-sectional side view of the obstructionremoval device of the obstruction removal system deployed within thevasculature, wherein a proximal end of the expandable member is beingslid toward a distal end of the expandable member, and wherein a middleportion of the expandable member is being folded over the distal end ofthe expandable member and at least a portion of the removal tool, sothat the obstruction is captured between the expandable member and theremoval tool, as the delivery tool is being removed from the vasculatureto remove the removal tool and the obstruction from the vasculature,wherein the intermediate catheter is used to urge the expandable memberto invert and/or fold over itself, in accordance with one or moreembodiments of the present disclosure.

FIG. 1E illustrates a cross-sectional side view of the obstructionremoval device of the obstruction removal system deployed within thevasculature, wherein the middle portion of the expandable member isfolded over the distal end of the expandable member and at least aportion of the removal tool, so that the obstruction is captured betweenthe expandable member and the removal tool, in accordance with one ormore embodiments of the present disclosure.

FIG. 1F illustrates a cross-sectional side view of the obstructionremoval device and the intermediate catheter of the obstruction removalsystem being pulled back through the guide catheter to remove theobstruction from the vasculature, in accordance with one or moreembodiments of the present disclosure.

FIG. 2A illustrates a cross-sectional side view of a guide catheter ofan obstruction removal system deployed within a vasculature, inaccordance with one or more embodiments of the present disclosure.

FIG. 2B illustrates a cross-sectional side view of an obstructionremoval device of the obstruction removal system deployed through theguide catheter, wherein the obstruction removal device includes aremoval tool and an expandable member attached to a delivery tool thatis fed through the guide catheter using an intermediate catheter, inaccordance with one or more embodiments of the present disclosure.

FIG. 2C illustrates a cross-sectional side view of the obstructionremoval device of the obstruction removal system deployed within thevasculature, wherein the intermediate catheter is pulled back (and/orthe delivery tool is pushed forward) to unsheathe the obstructionremoval device so that the obstruction removal device can engage theobstruction with the removal tool to at least partially separate theobstruction from an inner surface of the vasculature, in accordance withone or more embodiments of the present disclosure.

FIG. 2D illustrates a cross-sectional side view of the obstructionremoval device of the obstruction removal system deployed within thevasculature, wherein a proximal end of the expandable member is beinginverted and draped over the distal end of the expandable member and atleast a portion of the removal tool, so that the obstruction is capturedbetween the expandable member and the removal tool, as the delivery toolis being removed from the vasculature to remove the removal tool and theobstruction from the vasculature, in accordance with one or moreembodiments of the present disclosure.

FIG. 2E illustrates a cross-sectional side view of the obstructionremoval device of the obstruction removal system deployed within thevasculature, wherein the proximal end of the expandable member isinverted and draped over the distal end of the expandable member and atleast a portion of the removal tool, so that the obstruction is capturedbetween the expandable member and the removal tool, in accordance withone or more embodiments of the present disclosure.

FIG. 2F illustrates a cross-sectional side view of the obstructionremoval device and the intermediate catheter of the obstruction removalsystem being pulled back through the guide catheter to remove theobstruction from the vasculature, in accordance with one or moreembodiments of the present disclosure.

FIG. 3A illustrates a cross-sectional side view of the obstructionremoval device of the obstruction removal system including a passiveremoval tool in a deployed (expanded) configuration, in accordance withone or more embodiments of the present disclosure.

FIG. 3B illustrates a cross-sectional side view of the obstructionremoval device of the obstruction removal system including a passiveremoval tool in a deployed (expanded) configuration, wherein the passiveremoval tool is reinforced by an inner frame, in accordance with one ormore embodiments of the present disclosure.

FIG. 4A illustrates a cross-sectional side view of the obstructionremoval device of the obstruction removal system including an activeremoval tool in an undeployed (collapsed) configuration, in accordancewith one or more embodiments of the present disclosure.

FIG. 4B illustrates a cross-sectional side view of the obstructionremoval device of the obstruction removal system including an activeremoval tool in a deployed (expanded) configuration, in accordance withone or more embodiments of the present disclosure.

FIG. 4C illustrates a cross-sectional side view of the obstructionremoval device of the obstruction removal system including an activeremoval tool in a deployed (expanded) configuration, wherein the activeremoval tool is reinforced by an inner frame, in accordance with one ormore embodiments of the present disclosure.

FIG. 5A illustrates a cross-sectional side view of the obstructionremoval device of the obstruction removal system including an activeremoval tool in an undeployed (collapsed) configuration, in accordancewith one or more embodiments of the present disclosure.

FIG. 5B illustrates a cross-sectional side view of the obstructionremoval device of the obstruction removal system including an activeremoval tool in a deployed (expanded) configuration, in accordance withone or more embodiments of the present disclosure.

FIG. 5C illustrates a cross-sectional side view of the obstructionremoval device of the obstruction removal system including an activeremoval tool in a deployed (expanded) configuration, wherein the activeremoval tool is reinforced by an inner frame, in accordance with one ormore embodiments of the present disclosure.

DETAILED DESCRIPTION

Reference will now be made in detail to the subject matter disclosed,which is illustrated in the accompanying drawings. Referring generallyto FIGS. 1A through 5C, an obstruction removal system is described, inparticular, an obstruction removal system configured to selectivelydeploy a removal tool with an expandable member in a vasculature toreduce the risks associated with removal of an obstruction. Theexpandable member may be used to prevent the obstruction from dislodgingfrom the removal tool and passing to a potentially more dangerous area(e.g. causing a total blockage, blocking a portion of a vitalvasculature, etc.). In this regard, a physician may determine whether anobstruction is prone to risk and selectively deploy the removal toolwith the expandable member.

FIGS. 1A through 1F illustrate one or more embodiments of an obstructionremoval system 100. As shown in FIG. 1A, the obstruction removal system100 includes a guide catheter 104 (e.g., any suitable guide catheter,aspiration catheter, or any other suitable tube) configured to beinserted through a vasculature 102 to a position proximate to anobstruction 101. Referring now to FIG. 1B, the obstruction removalsystem 100 further includes an obstruction removal device comprising aremoval tool 110 and an expandable member 112 configured to be insertedthrough the guide catheter 104. For example, the removal tool 110 andthe expandable member 112 may be coupled or formed on/near a distal endof a delivery tool 108 that is configured to be inserted through theguide catheter 104. In embodiments, the delivery tool 108 may be a guidewire or tube. In this regard, the removal tool 110 may be fixed to thedistal end of the guide wire or tube, and the expandable member 112 maybe fixed or slidably coupled to the guide wire or tube at a positionnear the removal tool 110.

In embodiments, the obstruction removal device (i.e., the removal tool110 and the expandable member 112 on the delivery tool 108) may be atleast partially housed within an intermediate catheter 106 (e.g., anysuitable intermediate catheter, microcatheter, or any other suitabletube) during insertion. The intermediate catheter 106 may be used tocontain and keep the removal tool 110 and the expandable member 112 fromexpanding within the guide catheter 104. This may provide one or moreadvantages, such as, but not limited to, reducing friction between theremoval tool 110/expandable member 112 and the guide catheter 104,permitting the removal tool 110 and the expandable member 112 to beinserted through the distal opening of the guide catheter 104, andpreventing the removal tool 110/expandable member 112 from prematurelyengaging the obstruction 101.

FIG. 1B illustrates the obstruction removal device deployed within thevasculature 102 in proximity to an obstruction 101. The delivery tool108 (e.g., a guide wire and/or tube) is configured to be inserted withinthe guide catheter 104 and disposed proximate to the obstruction 101 inthe vasculature 102. For example, the delivery tool 108, carrying theend-mounted the removal tool 110 and the expandable member 112, may befed through the guide catheter 104 using the intermediate catheter 106to contain/sheathe the removal tool 110 and the expandable member 112during their insertion.

Referring now to FIG. 1C, the intermediate catheter 106 may beconfigured to unsheathe the removal tool 110 and the expandable member112 so that the removal tool 110 can engage the obstruction 101 in thevasculature 102. For example, after reaching a desired position withinthe vasculature 102, the intermediate catheter 106 may be pulled back(and/or the delivery tool 108 may be pushed forward relative to theintermediate catheter 106) to unsheathe the removal tool 110 and theexpandable member 112 so that the removal tool 110 can engage theobstruction 101.

The removal tool 110 is configured to at least partially separate theobstruction 101 from the inner surface of the vasculature 102 (e.g.,from the vessel wall). In embodiments, the removal tool 110 comprises aconical or umbrella-shaped section (e.g., a conical and/or umbrellashaped net-like structure or mesh) configured to at least partiallysurround the obstruction 101. In other embodiments, the removal tool 110comprises a differently shaped net-like structure or mesh configured toat least partially surround the obstruction 101 (e.g., a semi-circularor cylindrical structure, or the like).

In embodiments where the delivery tool 108 comprises a guide wiredisposed within a tube, the distal end of the removal tool 110 may beattached to the guide wire and another (mid) portion of the removal toolmay be attached to the tube so that moving the guide wire independent of(e.g., relative to) the tube causes the removal tool 110 to expand orcollapse, much like an umbrella. Additionally, or alternatively, theremoval tool 110 may be formed from a shape memory and/or super elasticalloy (e.g., Nitinol) so that the removal tool 110 automatically expandswhen it is unsheathed. For example, the removal tool 110 may be guidedpast the obstruction 101, unsheathed, and then pulled back toscrape/scoop the obstruction 101 off the inner surface of thevasculature 102.

The expandable member 112 includes a distal end 114 that is fixedly orslidably coupled to the delivery tool 110 and a proximal end 116 that isslidably coupled to the delivery tool 110. The expandable member 112 maybe positioned so that, during its deployment, the distal end 114 islocated in between the removal tool 110 and the proximal end 116.

As shown in FIG. 1D, when the delivery tool 108 is withdrawn (e.g.,pulled back into the guide catheter 104 and/or intermediate catheter106), the proximal end 116 of the expandable member 112 may beconfigured to slide toward the distal end 114 of the expandable member112, thereby causing the expandable member 112 to surround at least aportion of the obstruction 101 and the removal tool 110 so that theobstruction 101 is captured between the expandable member 112 and theremoval tool 110. In embodiments, when the proximal end 116 of theexpandable member 112 slides toward the distal end 114 of the expandablemember 112 as a result of the delivery tool 108 being removed from thevasculature 102 to remove the removal tool 110 and the obstruction 101from the vasculature 102, a middle portion 118 of the expandable member112 is configured to fold over the distal end 114 of the expandablemember 112 and at least a portion of the removal tool 110, so that theobstruction 101 is captured between the expandable member 112 and theremoval tool 110. For example, when the delivery tool 108 is pulled backthrough the guide catheter 104 and/or intermediate catheter 106, theresulting friction between the middle portion 118 of the expandablemember 112 and the inner surface of the vasculature 102 (e.g., as shownFIG. 1D-1 ), the guide catheter 104, or the intermediate catheter 106may cause the middle portion of the expandable member 112 to fold overthe removal tool 110 so that the obstruction 101 is captured between theexpandable member 112 and the removal tool 110. Additionally, oralternatively, when the delivery tool 108 is pulled back through theguide catheter 104 and/or intermediate catheter 106, the resistance fromfluid in the vasculature 102 may cause the middle portion of theexpandable member 112 to fold over the removal tool 110 so that theobstruction 101 is captured between the expandable member 112 and theremoval tool 110. Furthermore, as shown in FIG. 1D-2 , in someembodiments, the intermediate catheter 106 (or guide catheter 104) maybe used to urge the expandable member 112 to invert and/or fold overitself.

FIG. 1E illustrates the obstruction 101 captured between the expandablemember 112 and the removal tool 110, as the delivery tool 108 is beingwithdrawn from the vasculature 102 to remove the removal tool 110 andthe obstruction 101 from the vasculature 102. For example, the deliverytool 108 may be pulled back into the guide catheter 104 and/orintermediate catheter 106 to remove the obstruction 101 that is capturedbetween the expandable member 112 and the removal tool 110 from thevasculature 102.

As shown in FIG. 1F, the intermediate catheter 106 with the deliverytool 108 and the obstruction 101 that is captured between the expandablemember 112 and the removal tool 110 may be pulled back through the guidecatheter 104 to remove the obstruction 101 from the vasculature 102. Thedelivery tool 108 with the obstruction removal device (including removaltool 110 and expandable member 112) and the obstruction 101 may bewithdrawn through the intermediate catheter 106, as depicted in FIG. 1F.Alternatively, the delivery tool 108 with the obstruction 101 that iscaptured between the expandable member 112 and the removal tool 110 maybe pulled directly through the guide catheter 104 (without use of anintermediate catheter 106).

FIGS. 2A through 2F illustrate another embodiment of the obstructionremoval system 100, wherein the expandable member 112 has a distal end114 coupled to the delivery tool 108 and a proximal end 116 that isconfigured to move freely. For example, the expandable member 112 maycomprise a conical/umbrella-shaped net or mesh structure with one endfixedly or slidably coupled to the delivery tool 108 and one free/openend.

As shown in FIGS. 2B and 2C, when the obstruction removal device (i.e.,the removal tool 110 and the expandable member 112 on the delivery tool108) is being guided through the vasculature 102 to the obstruction 101,the expandable member 112 may be oriented so that the proximal end 116of the expandable member 112 is facing away from the removal tool 110.Then, as shown in FIG. 2D, when the delivery tool 108 is withdrawn(e.g., pulled back into the guide catheter 104 and/or intermediatecatheter 106), the proximal end 116 of the expandable member 112 may beconfigured to invert toward the distal end 114 of the expandable member112, thereby causing the expandable member 112 to surround at least aportion of the obstruction 101 and the removal tool 110 so that theobstruction 101 is captured between the expandable member 112 and theremoval tool 110. In embodiments, the proximal end 116 of the expandablemember 112 is configured to invert and drape over the distal end 114 ofthe expandable member 112 and at least a portion of the removal tool 110as the delivery tool 108 is withdrawn from the vasculature 102 to removethe removal tool 110 and the obstruction 101 from the vasculature 102.For example, when the delivery tool 108 is pulled back through the guidecatheter 104 and/or intermediate catheter 106, the resulting frictionbetween the proximal (i.e., free) end 116 of the expandable member 112and the inner surface of the vasculature 102, the guide catheter 104, orthe intermediate catheter 106 may cause the expandable member 112 toinvert and drape over the removal tool 110 so that the obstruction 101is captured between the expandable member 112 and the removal tool 110.Additionally, or alternatively, when the delivery tool 108 is pulledback through the guide catheter 104 and/or intermediate catheter 106,the resistance from fluid in the vasculature 102 may cause theexpandable member 112 to invert and drape over the removal tool 110 sothat the obstruction 101 is captured between the expandable member 112and the removal tool 110.

FIG. 2E illustrates the obstruction 101 captured between the expandablemember 112 and the removal tool 110, as the delivery tool 108 is beingwithdrawn from the vasculature 102 to remove the removal tool 110 andthe obstruction 101 from the vasculature 102. For example, the deliverytool 108 may be pulled back into the guide catheter 104 and/orintermediate catheter 106 to remove the obstruction 101 that is capturedbetween the expandable member 112 and the removal tool 110 from thevasculature 102.

As shown in FIG. 2F, the intermediate catheter 106 with the deliverytool 108 and the obstruction 101 that is captured between the expandablemember 112 and the removal tool 110 may be pulled back through the guidecatheter 104 to remove the obstruction 101 from the vasculature 102. Thedelivery tool 108 with the obstruction removal device (including removaltool 110 and expandable member 112) and the obstruction 101 may bewithdrawn through the intermediate catheter 106, as depicted in FIG. 2F.Alternatively, the delivery tool 108 with the obstruction 101 that iscaptured between the expandable member 112 and the removal tool 110 maybe pulled directly through the guide catheter 104 (without use of anintermediate catheter 106).

Referring now to FIGS. 3A through 5C, various embodiments of the removaltool 110 are shown and described. Embodiments of the removal tool 110illustrated in FIGS. 3A through 5C may be employed with any embodimentsof the obstruction removal system 100 illustrated in FIGS. 1A through 2For otherwise described herein.

In embodiments, such as those illustrated in FIGS. 3A and 3B, theobstruction removal device may include a passive removal tool 110. Inthis regard, the removal tool 110 may be configured to expand upondeployment (e.g., unsheathing) from the intermediate catheter 106. Theremoval tool 110 may include a distal end 109 (e.g., tip coil) that isfixed to a distal end of the delivery tool 108 (e.g., delivery tube orwire) and a proximal end 111 that is fixed or slidably coupled toanother portion of the delivery tool 108 such that an obstructionlanding area 120 on the delivery tool 108 is defined between theproximal end 111 of the removal tool 110 and the distal end 114 of theexpandable member 112. In some embodiments, the ends of the removal tool110 and/or expandable member 112 comprise marker bands that are coupledto the delivery tool 108.

FIGS. 4A through 4C illustrate embodiments of the obstruction removaldevice including an active removal tool 110. In this regard, the removaltool 110 may be selectively expanded or collapsed. For example, theremoval tool 110 may be expanded or collapsed by actuating two portionsof a delivery tool 108 (e.g., a delivery wire 108A and a delivery tube108B) relative to one another. The removal tool 110 may include a distalend 109 (e.g., tip coil) that is fixed to a distal end of the deliverywire 108A and a proximal end 111 that is fixed to a distal end of thedelivery tube 108B, either directly or via an obstruction landing area120 between the proximal end 111 of the removal tool 110 and the distalend 114 of the expandable member 112 (as shown).

In embodiments, the expandable member 112 may be coupled to the deliverytube 108B such that the obstruction landing area 120 is defined betweenthe proximal end 111 of the removal tool 110 and the distal end 114 ofthe expandable member 112. The obstruction landing area 120 may comprisea wire mesh portion that connects the removal tool 110 and theexpandable member 112 together. In some embodiments, the expandablemember 112 and the removal tool 110 may be portions of a continuous wiremesh structure.

The ends of the removal tool 110 and/or expandable member 112 maycomprise marker bands that are coupled to respective portions of thedelivery wire 108A and tube 108B. As shown in FIGS. 4A and 4B,respectively, the removal tool 110 may be collapsed by pushing thedelivery wire 108A through the delivery tube 108B (or pulling thedelivery tube 108B away from the distal end of the delivery wire 108A)and may expanded by pulling the delivery wire 108A through the deliverytube 108B (or pushing the delivery tube 108B toward the distal end ofthe delivery wire 108A).

FIGS. 5A through 5C illustrate embodiments of the obstruction removaldevice including an active removal tool 110 and an active expandablemember 112. In this regard, the removal tool 110 and the expandablemember 112 may be selectively expanded or collapsed. For example, theremoval tool 110 may be expanded or collapsed by actuating two portionsof a delivery tool 108 (e.g., a delivery wire 108A and a delivery tube108B) relative to one another. The removal tool 110 may include a distalend 109 (e.g., tip coil) that is fixed to a distal end of the deliverywire 108A and a proximal end 111 that is connected to the distal end 114of the expandable member 112 via an obstruction landing area 120 betweenthe proximal end 111 of the removal tool 110 and the distal end 114 ofthe expandable member 112. The obstruction landing area 120 may comprisea wire mesh portion that connects the removal tool 110 and theexpandable member 112 together. In some embodiments, the expandablemember 112 and the removal tool 110 may be portions of a continuous wiremesh structure.

The ends of the removal tool 110 and/or expandable member 112 maycomprise marker bands that are coupled to respective portions of thedelivery wire 108A and tube 108B. As shown in FIGS. 5A through 5C, theproximal end 116 of the expandable member 112 may be coupled to a distalend of the delivery tube 108B so that pulling the delivery tube 108Bback relative to the delivery wire 108A (or extending the delivery wire108A forward relative to the delivery tube 108B) causes the removal tool110 and the expandable member 112 to collapse; and conversely, pullingthe delivery wire 108A back relative to the delivery tube 108B (orpushing the delivery tube 108B forward relative to the delivery wire108A) causes the removal tool 110 and the expandable member 112 toexpand.

As shown in FIGS. 3B, 4C, and 5C, in some embodiments, the removal tool110 may include a support frame 122 (e.g., one or more rigid orsemi-rigid structures) that provide structural reinforcement for theremoval tool 110 when the removal tool 110 is in a deployed (i.e.,expanded) configuration. The support frame 122 may be configured tocollapse (e.g., fold toward the delivery tool 108) when the removal tool110 is in a collapsed configuration. Additionally, or alternatively, theremoval tool 110 may include non-uniform wire mesh. For example, theremoval tool 110 structure may comprise thicker, stronger, and/or denserwire mesh toward the distal end 109 of the removal tool 110 to provide astronger conical/funnel shaped structure when the removal tool 110 isdeployed/expanded and thinner, weaker, and/or less dense wire meshtoward the proximal end 111 of the removal tool 110 to provideflexibility for the removal tool 110 to expand/collapse more easily.

In the embodiments illustrated in FIGS. 1A through 5C, or combinationsthereof, the expandable member 112 may be configured to transitionbetween contracted/collapsed and expanded states. The expandable member112 may be configured to transition between the contracted and expandedstates in any suitable way, including, but not limited to, unsheathingthe expandable member 112 to allow expansion and sheathing/re-sheathingthe expandable member 112 to induce contraction.

The expanded state may allow the expandable member 112 to surround atleast a portion of the removal tool 110 and/or the obstruction 101. Thecontracted state may be suitable for insertion and removal of theobstruction removal device (including expandable member 112 and removaltool 110) through the guide catheter 104 and/or intermediate catheter106. For example, when the expandable member 112 is in thecollapsed/contracted state, after surrounding at least a portion of theremoval tool 110 and/or the obstruction 101, the expandable member 112and the removal tool 110 may be withdrawn through the guide catheter 104and/or the intermediate catheter 106 to remove the obstruction 101 fromthe vasculature 102.

Benefits of surrounding at least a portion of the removal tool 110and/or the obstruction 101 with the expandable member 112 may include,but are not limited to, smaller cross-sectional area, reduced frictionon a vessel wall, reduced likelihood of catching on an opening of theguide catheter 104 and/or intermediate catheter 106, and reducedlikelihood of obstruction dislodgement.

Referring generally to embodiments of the obstruction removal system 100disclosed herein, the expandable member 112 may be configured totransition between a first configuration and a second configuration, orbetween a contracted state and an expanded state, in any number of ways,including, but not limited to, unsheathing (e.g., withdrawal of theintermediate catheter 106 or extension through the guide catheter 104),disengagement of locking members (e.g., wires, hooks, etc.) attached tothe expandable member 112, use of shape memory alloys (e.g., Nitinol),or the like. It is envisioned that when the expandable member is in anexpanded state, the expandable member may take up a substantial portionof the cross-section of the vasculature 102.

In embodiments, the expandable member 112, removal tool 110, and theobstruction 101 are withdrawn into the guide catheter 104 and removedfrom the vasculature 102. In some embodiments, the expandable member112, removal tool 110, and the obstruction 101 may be further withdrawninto the intermediate catheter 106. The expandable member 112 maysurround at least a portion of the obstruction 101 to prevent dislodgingand may also assist in compressing the obstruction 101 into the guidecatheter 104 and/or the intermediate catheter 106 (e.g., by tension,cinching, crimping, etc.).

Surrounding at least a portion of the removal tool 110 and/orobstruction 101 with the expandable member 112 may serve severalfunctions including, but not limited to, reducing a likelihood that theremoval tool 110 snags (e.g. on an inner surface/vessel wall of thevasculature 102 or an opening of the guide catheter 104), reducing aprofile of the obstruction 101 for removal through the guide catheter104 and/or intermediate catheter 106, and/or securing the obstruction101 to prevent dislodgement from the removal tool 110.

In embodiments, the removal tool 110 and/or expandable member 112 maycomprise a wire mesh. Such a wire mesh may include wires made of aflexible material (e.g. nitinol, cobalt chromium, polymer mesh (e.g.,PET or nylon), or the like), where the wires (e.g. 16 to 288 or morewires), have a certain diameter (e.g. from 0.0005 inches to 0.0050inches), and have certain material properties (e.g. strength,coefficient of friction with blood, resistance to plastic deformation,etc.) suitable for engaging the obstruction 101 and/or removal tool 110.The wire mesh can be can be single ply or multiple plies. Furthermore,the wire mesh may include various sets of wires (e.g. support wires withlarger diameters, wires to engage a vessel wall, wires to engage aportion of the obstruction or obstruction removal device, radiopaque orradiodense wires, etc.).

Any number of the presently disclosed elements may be suitable forimaging by a non-invasive imaging technology (e.g. X-ray, CT scans,etc.). For instance, the guide catheter 104, intermediate catheter 106,delivery tool 108, removal tool 110, expandable member 112, and/or anyadditional components may comprise radiodense or radiopaque material(e.g. titanium, tungsten, barium sulfate, zirconium oxide, Drawn FilledTube (DFT), or the like) suitable for insertion in a human body. In someembodiments, the removal tool 110 and the expandable member 112 are bothportions of a common wire mesh structure formed from a radiodense orradiopaque material (e.g. DFT).

It is to be understood that any number of components of the obstructionremoval system 100 may be attached by any suitable means including, butnot limited to, welding, adhesive, mechanical fastening, interferencefittings, etc. For example, the delivery tool 108 may be attached to theremoval tool 110 and/or expandable member 112 by such means.Alternatively, or additionally, two or more of the components may beportions of a common structure (e.g., a common mold or print).

It is envisioned that there may be multiple orders in which one or moredevices of the obstruction removal system 100 are deployed. Factors fordetermining an order may include, but are not limited to, vasculatureproperties (e.g. vasculature size, vasculature geometries, branches ofthe vasculature, vasculature wall strength, etc.), blood pressure, bloodflow direction, duration of operation (i.e. does patient require areduced operating time for safety concerns), size of obstruction, or theconfiguration of the obstruction removal device.

Referring generally to FIGS. 1A through 5C, a method of removing anobstruction from a vasculature 102 may include, but is not limited to,the steps of: deploying the guide catheter 104 through the patient'svasculature 102 to a position near the obstruction 101; extending thedelivery tool 108 with the end-mounted removal tool 110 through theguide catheter 104 so that the distal end of the delivery tool 108 isdisposed proximate to the obstruction 101 in the vasculature 102(with/without the use of the intermediate catheter 106); removing atleast a portion of the obstruction 101 in the vasculature 102 by atleast partially separating the obstruction 101 from an inner surface ofthe vasculature 102 with the removal tool 110; and surrounding at leasta portion of the obstruction 101 and the removal tool 110 with theexpandable member 112, wherein the proximal end 116 of the expandablemember 112 is configured to invert or slide toward the distal end 114 ofthe expandable member 112, so that the obstruction 101 is capturedbetween the expandable member 112 and the removal tool 110, when thedelivery tool 108 is withdrawn from the vasculature 102 to remove theremoval tool 110 and the obstruction 101 from the vasculature 102.

It is to be understood that implementations of the methods disclosedherein may include one or more of the steps described herein. Further,such steps may be carried out in any desired order and, in someimplementations, two or more of the steps may be carried outsimultaneously with one another. Two or more of the steps disclosedherein may be combined in a single step, and in some implementations,one or more of the steps may be carried out as two or more sub-steps.Further, other steps or sub-steps may be carried in addition to, or assubstitutes to one or more of the steps disclosed herein.

It is also to be understood that usage of terminology in the presentdisclosure is not intended to be limiting. For example, as used herein,an “obstruction” may refer to any vascular obstruction, including butnot limited to, a blood clot, plaque (e.g. fat, cholesterol, etc.),internal structure/growth, foreign object, or the like.

Although the technology has been described with reference to theembodiments illustrated in the attached drawing figures, equivalents maybe employed and substitutions made herein without departing from thescope of the technology as recited in the claims. Components illustratedand described herein are merely examples of a device and components thatmay be used to implement the embodiments of the present invention andmay be replaced with other devices and components without departing fromthe scope of the invention. Furthermore, any dimensions, degrees, and/ornumerical ranges provided herein are to be understood as non-limitingexamples unless otherwise specified in the claims.

What is claimed is:
 1. An obstruction removal system, comprising: aguide catheter configured to be inserted within a vasculature; adelivery tool having a distal end configured to be inserted within theguide catheter and disposed proximate to an obstruction in thevasculature; and a continuous wire mesh structure coupled to thedelivery tool, wherein respective portions of the continuous wire meshstructure form: a removal tool disposed at the distal end of thedelivery tool and configured to at least partially separate theobstruction from an inner surface of the vasculature, wherein theremoval tool comprises a conical or umbrella-shaped section configuredto at least partially surround the obstruction; an expandable membercoupled to the delivery tool, the expandable member including a proximalend that is slidably coupled to the delivery tool, wherein the proximalend of the expandable member is configured to invert or slide toward adistal end of the expandable member, thereby causing the expandablemember to surround at least a portion of the obstruction and the removaltool so that the obstruction is captured between the expandable memberand the removal tool, when the delivery tool is withdrawn from thevasculature to remove the removal tool and the obstruction from thevasculature; and an obstruction landing area between the removal tooland the expandable member, wherein the removal tool, the expandablemember, and the obstruction landing area are separated by marker bandsthat are coupled to the delivery tool.
 2. The obstruction removal systemof claim 1, wherein the distal end of the expandable member is fixedlyor slidably coupled to the delivery tool.
 3. The obstruction removalsystem of claim 1, wherein the proximal end of the expandable member isslidably coupled to the delivery tool and is configured to slide towardthe distal end of the expandable member when the delivery tool iswithdrawn from the vasculature to remove the removal tool and theobstruction from the vasculature, and wherein a middle portion of theexpandable member is configured to fold over the distal end of theexpandable member and at least a portion of the removal tool, so thatthe obstruction is captured between the expandable member and theremoval tool, when the proximal end of the expandable member slidestoward the distal end of the expandable member as the delivery tool iswithdrawn from the vasculature to remove the removal tool and theobstruction from the vasculature.
 4. The obstruction removal system ofclaim 1, further comprising: an intermediate catheter configured tosheathe the removal tool and the expandable member while the deliverytool is inserted within the guide catheter and guided into thevasculature.
 5. The obstruction removal system of claim 4, wherein theintermediate catheter is further configured to unsheathe the removaltool and the expandable member to allow the removal tool to at leastpartially separate the obstruction from the inner surface of thevasculature.
 6. The obstruction removal system of claim 1, wherein thedelivery tool comprises at least one of a guide wire or a tube.
 7. Anobstruction removal device, comprising: a continuous wire mesh structurecoupled to a delivery tool, wherein respective portions of thecontinuous wire mesh structure form: a removal tool disposed at a distalend of the delivery tool and configured to at least partially separatean obstruction from an inner surface of a vasculature, wherein theremoval tool comprises a conical or umbrella-shaped section configuredto at least partially surround the obstruction; an expandable membercoupled to the delivery tool, the expandable member including a proximalend that is slidably coupled to the delivery tool, wherein the proximalend of the expandable member is configured to invert or slide toward adistal end of the expandable member, thereby causing the expandablemember to surround at least a portion of the obstruction and the removaltool so that the obstruction is captured between the expandable memberand the removal tool when the delivery tool is withdrawn from thevasculature to remove the removal tool and the obstruction from thevasculature; and an obstruction landing area between the removal tooland the expandable member, wherein the removal tool, the expandablemember, and the obstruction landing area are separated by marker bandsthat are coupled to the delivery tool.
 8. The obstruction removal deviceof claim 7, wherein the distal end of the expandable member is fixedlyor slidably coupled to the delivery tool.
 9. The obstruction removaldevice of claim 7, wherein the proximal end of the expandable member isslidably coupled to the delivery tool and is configured to slide towardthe distal end of the expandable member when the delivery tool iswithdrawn from the vasculature to remove the removal tool and theobstruction from the vasculature, and wherein a middle portion of theexpandable member is configured to fold over the distal end of theexpandable member and at least a portion of the removal tool, so thatthe obstruction is captured between the expandable member and theremoval tool, when the proximal end of the expandable member slidestoward the distal end of the expandable member as the delivery tool iswithdrawn from the vasculature to remove the removal tool and theobstruction from the vasculature.